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  • GOP lawmakers urge FDA to reject Chinese trial data unless sites undergo recent agency audit
    Two Republican members of the U.S. House have asked the Food and Drug Administration to tighten its oversight of clinical data that originates from China. Their proposal would require the FDA to r…
    Endpoints · 2mo agoRegulatoryNegative↗ source
  • Fromm Family Foods recalls over 5,800 cases of wet dog food in US and Canada over possible metal contamination
    Fromm Family Foods LLC announced on August 21, 2026 that it is voluntarily recalling 3,852 cases of its Turkey Pâté Wet dog food and 1,973 cases of its Diner Classics Milo's Meatloaf Pâté Wet dog f…
    fda recalls · 2mo agoRegulatoryNegative↗ source
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  • California chronic pain biotech co‑founded by Vivek Ramaswamy to go public via reverse merger
    A California biotech company that has developed a chronic pain medication already approved for use in Italy is preparing to list on a U.S. exchange. The firm, co‑founded by entrepreneur Vivek Rama…
    Endpoints · 2mo agoDealNeutral↗ source
  • Moderna’s melanoma vaccine trial success sparks $45 billion market value surge
    Moderna’s shares jumped more than 170% after the company announced that its experimental melanoma vaccine, intismeran, met its primary goals in a Phase 3 trial. The surge added roughly $45 billion…
    BioPharma Dive · 2mo agoPositive readoutPositive↗ source
  • Gray‑market copies of Lilly’s obesity drug retatrutide show weaker weight‑loss results, study finds
    A recent study examined the effectiveness of gray‑market versions of Eli Lilly’s triple‑agonist obesity drug retatrutide. The analysis found that patients using these unapproved copies experienced…
    Endpoints · 2mo agoNegative readoutNegative↗ source
  • FDA grants approval to Ultragenyx's Genglycos gene therapy for ultra-rare glycogen storage disorder
    Ultragenyx announced that the U.S. Food and Drug Administration has approved its gene therapy called Genglycos. The therapy targets an ultra-rare glycogen storage disorder that can lead to severe…
    Endpoints · 2mo agoApprovalPositive↗ source
  • Three deaths in China’s investigator-initiated trials raise concerns over fast, low-cost clinical testing
    Three participants died while taking part in investigator-initiated trials in China, prompting renewed scrutiny of the country’s clinical testing practices. China’s system is prized for its low co…
    Endpoints · 2mo agoRegulatoryNegative↗ source
  • Ultragenyx secures FDA approval for Glenglycos, first gene therapy for GSD Ia
    Ultragenyx announced FDA approval of Glenglycos, a one-time gene therapy for glycogen storage disease type Ia, a rare genetic disorder. The therapy delivers a functional gene to the liver to resto…
    BioPharma Dive · 2mo agoApprovalPositive↗ source
  • Eli Lilly teams with Amplitude on taRNA vaccine platform as Otsuka ends psychedelic trial
    Eli Lilly announced a collaboration with Amplitude Therapeutics to co‑develop vaccine candidates using a trans‑amplifying RNA (taRNA) platform. The taRNA approach aims to boost antigen expression…
    Endpoints · 2mo agoDealNeutral↗ source
  • FDA rejects Osteal Therapeutics' combo therapy for joint-implant infections
    The U.S. Food and Drug Administration rejected Osteal Therapeutics' lead combination therapy late last month. The agency cited concerns that prevented approval of the product intended to treat infe…
    Endpoints · 2mo agoRegulatoryNegative↗ source
  • Regeneron wins FDA approval for Pasatru, targeting rare bone disease FOP
    The U.S. Food and Drug Administration has approved Regeneron Pharmaceuticals' drug Pasatru for the treatment of fibrodysplasia ossificans progressiva (FOP), a very rare condition in which muscle an…
    BioPharma Dive · 2mo agoApprovalPositive↗ source
  • PhRMA weighs former Republican lawmakers and Trump administration officials for CEO role
    PhRMA, the pharma lobbying group, has been searching for a new chief executive for over four months. The search has focused on candidates with Republican backgrounds, including former members of C…
    Endpoints · 2mo agoNeutral↗ source
  • FDA expands TEMPO pilot with new digital health partners Limbic, Cadence and Dexcom
    The FDA is quietly building a pilot program called TEMPO to test a “try first, evaluate later” approach for digital health devices. The agency has added the behavioral‑health firm Limbic to the ro…
    Endpoints · 2mo agoRegulatoryNeutral↗ source
  • WuXi Bio sells majority stake in chromatography resin maker Bestchrom; Cabaletta adds new CDMO partner
    WuXi Bio announced it will divest its 51.1% equity interest in Bestchrom, a Shanghai-based supplier of chromatography resins. The sale will transfer control to an unnamed third party, marking WuXi…
    Endpoints · 2mo agoDealNeutral↗ source
  • Epic expands AI tools for clinicians and patients, intensifying competition for health-tech startups
    Epic highlighted its growing portfolio of artificial‑intelligence applications for both clinicians and patients at its annual Users Group Meeting in Verona, Wisconsin. The presentation showcased ne…
    Endpoints · 2mo agoNeutral↗ source
  • FDA approves Regeneron’s garetosmab for ultra-rare bone-forming disease
    The FDA has granted approval to Regeneron's antibody garetosmab, which targets activin A, for the treatment of fibrodysplasia ossificans progressiva (FOP). FOP is an ultra‑rare disorder that causes…
    Endpoints · 2mo agoApprovalPositive↗ source
  • Moderna-Merck mRNA cancer vaccine shows landmark interim success in melanoma trial
    An interim analysis of a Phase 3 trial of an individualized mRNA cancer vaccine from Moderna and Merck showed the treatment met its primary goals. The vaccine, given together with Merck's immunothe…
    BioPharma Dive · 2mo agoPositive readoutPositive↗ source
  • Merck and Moderna report Phase 3 success for personalized mRNA cancer vaccine intismeran autogene
    Merck and Moderna announced on August 19, 2026 that their personalized mRNA cancer vaccine, intismeran autogene, has completed a successful Phase 3 trial. The collaboration aims to create a patient…
    Endpoints · 2mo agoPositive readoutPositive↗ source
  • Moderna cancer vaccine data lifts investor confidence, shares jump to multi-year highs
    Moderna has long said it wants to broaden its portfolio beyond infectious-disease vaccines. The company has been working on a cancer vaccine and investors have been waiting for late-stage trial res…
    Endpoints · 2mo agoPositive readoutPositive↗ source
  • B. Braun voluntarily recalls one lot of Excel Lactated Ringers IV solution over particulate contamination
    B. Braun Medical Inc announced a voluntary recall of a specific lot of its Excel Lactated Ringers Injection, a 1000 mL IV solution, after detecting particulate matter in the product. Laboratory an…
    fda recalls · 2mo agoCRLNegative↗ source
  • Trump nominates Heidi Overton as FDA commissioner, known for criticism of vaccine mandates and abortion pills
    President Donald Trump announced Heidi Overton as his nominee for FDA commissioner, marking the start of a new chapter for the agency. Overton has previously voiced criticism of vaccine requiremen…
    Endpoints · 2mo agoRegulatoryNeutral↗ source
  • Trump administration eyes Heidi Overton as next FDA commissioner
    President Donald Trump is reported to be preparing a nomination for Heidi Overton to become the next commissioner of the Food and Drug Administration, according to multiple news outlets. Overton i…
    BioPharma Dive · 2mo agoRegulatoryNeutral↗ source
  • Biokin's EGFR-HER3 bispecific ADC succeeds in late-stage Chinese lung cancer trial
    Chinese biotech Biokin announced that its EGFRxHER3 bispecific antibody-drug conjugate met its primary endpoint in a late-stage trial in a genetically defined subset of non-small cell lung cancer (…
    Endpoints · 2mo agoPositive readoutPositive↗ source
  • Federal appeals court revives portion of Teva's Medicare price-negotiation lawsuit amid Austedo discount plans
    Federal appeals court in the D.C. Circuit issued a decision Tuesday that partially overturns a lower‑court ruling that had dismissed Teva's challenge to Medicare's drug pricing negotiations. The r…
    Endpoints · 2mo agoRegulatoryNeutral↗ source
  • Trump expected to nominate Heidi Overton as new FDA commissioner
    President Donald Trump is expected to nominate Heidi Overton as the next commissioner of the U.S. Food and Drug Administration, according to a source familiar with the decision. Overton's selectio…
    Endpoints · 2mo agoRegulatoryNeutral↗ source